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A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin

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ClinicalTrials.gov Identifier: NCT00530946
Recruitment Status : Completed
First Posted : September 18, 2007
Results First Posted : April 13, 2009
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period

Condition or disease Intervention/treatment Phase
Hypertension Hypercholesterolemia Drug: Amlodipine 2.5mg/Atorvastatin 5mg Drug: Amlodipine 2.5mg/Atorvastatin 10mg Drug: Amlodipine 5mg/Atorvastatin 5mg Drug: Amlodipine 5mg/Atorvastatin 10mg Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin In The Treatment Of Concurrent Hypertension And Hyper-LDL-Cholesterolemia
Study Start Date : September 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: CI-1038 2.5mg/5mg Drug: Amlodipine 2.5mg/Atorvastatin 5mg
Single pill combination, dosed once daily for 8 weeks
Active Comparator: CI-1038 2.5mg/10mg Drug: Amlodipine 2.5mg/Atorvastatin 10mg
Single pill combination, dosed once daily for 8 weeks
Active Comparator: CI-1038 5mg/5mg Drug: Amlodipine 5mg/Atorvastatin 5mg
Single pill combination, dosed once daily for 8 weeks
Active Comparator: CI-1038 5mg/10mg Drug: Amlodipine 5mg/Atorvastatin 10mg
Single pill combination, dosed once daily for 8 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Change in Systolic Blood Pressure [ Time Frame: 8 weeks ]
    Value at Week 8 minus value at baseline

  2. Percent Change in Low Density Lipoprotein-Cholesterol [ Time Frame: 8 weeks ]
    Percent of "value at Week 8 minus value at baseline" over value at baseline


Secondary Outcome Measures :
  1. Change in Systolic Blood Pressure From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks, and 8 weeks ]
    Value at Week 2, Week 4, or Week 8 minus value at baseline

  2. Change in Diastolic Blood Pressure From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ]
    Value at Week 2, Week 4, or Week 8 minus value at baseline

  3. Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ]
    Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline

  4. Percent Change in Total Cholesterol From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ]
    Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline

  5. Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ]
    Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline

  6. Percent Change in Triglycerides From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ]
    Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline

  7. Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks, and 8 weeks ]
    Value at Week 2, Week 4, or Week 8 minus value at baseline

  8. Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ]
    Value at Week 2, Week 4, or Week 8 minus value at baseline

  9. Change in Apolipoprotein B From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks, and 8 weeks ]
    Value at Week 2, Week 4, or Week 8 minus value at baseline


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The out-patient with concurrent hypertension and hyper-LDL-cholesterolemia is a male or female >=20 to <80 years of age at Visit 1.
  • The SBP at Visit 4 (Week -1) and Visit 5 (Week 0) is continuously SBP >=140 mmHg and <180 mmHg,
  • LDL-C >=140 mg/dL and <250 mg/dL at Visit 3 (Week -2) and 4 (Week -1).

Exclusion Criteria:

  • Subjects who had experienced the following coronary artery disease within the past 3 months.
  • Myocardial infarction
  • Receiving PCI（percutaneous coronary intervention）or CABG (coronary artery bypass grafting)
  • Any clinically meaningful valvular disease
  • Subjects with a history of cerebrovascular diseases such as stroke or transient ischemic attack within the past 3 months.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530946


Locations
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Japan
Pfizer Investigational Site
Fukuoka-shi, Fukuoka-ken, Japan
Pfizer Investigational Site
Kitakyushu-shi, Fukuoka-ken, Japan
Pfizer Investigational Site
Kurume-shi, Fukuoka-ken, Japan
Pfizer Investigational Site
Maebaru-shi, Fukuoka-ken, Japan
Pfizer Investigational Site
Annaka, Gunma, Japan
Pfizer Investigational Site
Sapporo-shi, Hokkaido, Japan
Pfizer Investigational Site
Teine, Hokkaido, Japan
Pfizer Investigational Site
Yokohama-shi, Kanagawa-ken, Japan
Pfizer Investigational Site
Yamashita-cho, Naka-ku, Kanagawa-ken, Japan
Pfizer Investigational Site
Kita-ku, Osaka-fu, Japan
Pfizer Investigational Site
Koshigaya-shi, Saitama-ken, Japan
Pfizer Investigational Site
Chofu, Tokyo, Japan
Pfizer Investigational Site
Kiyose, Tokyo, Japan
Pfizer Investigational Site
Setagaya-ku, Tokyo, Japan
Pfizer Investigational Site
Shinagawa-Ku, Tokyo, Japan
Pfizer Investigational Site
Shinagawa, Tokyo, Japan
Pfizer Investigational Site
Osaka, Japan
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00530946     History of Changes
Other Study ID Numbers: A3841058
First Posted: September 18, 2007    Key Record Dates
Results First Posted: April 13, 2009
Last Update Posted: November 27, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Hypertension
Hypercholesterolemia
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Amlodipine
Amlodipine, atorvastatin drug combination
Atorvastatin
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents